Dallas, Plano Researchers Test New Device to Treat Advanced Heart Failure

Baylor Research Institute enrolling patients in HeartMate trial of new long-term option

Researchers at Baylor Annette C. and Harold C. Simmons Transplant Institute and The Heart Hospital Baylor Plano have begun studying a next-generation heart device that could give long-term solutions for patients with advanced heart failure. At about the size of a small doorknob, the device—the HeartMate III™ Left Ventricular Assist System (LVAS)—helps circulate blood through the body and could help certain patients avoid heart transplant surgery.

The research is part of "Momentum III," a nationwide trial by Thoratec Corporation, which also manufactured the previous generations of the device: the HeartMate I and HeartMate II. The new trial compares the HeartMate III with the FDA-approved HeartMate II to determine if the new device is both safer and more effective for people whose hearts don't function properly and either don't want or don't qualify for a heart transplant.

Half the size of its HeartMate II predecessor, the HeartMate III device attaches to the heart's wall, with one end connecting to the organ's aorta. An external battery system powers the device, which can pump up to 10 liters of blood per minute. The new version of the technology is designed to reduce complications, which can include infection, bleeding and thromboembolic events.

"The science behind the new design is sound, so we hope this will decrease the risk of complications," said Shelley A. Hall, MD, FACC, chief of transplant cardiology and mechanical circulatory support/heart failure at Baylor University Medical Center at Dallas. "Technology is continuing to move forward at a much faster rate than our ability to treat heart failure with pills or by modifying the immune system after transplant. This is a very promising therapy for our patients with advanced heart failure."

Momentum III takes place amidst a growing trend of patients who use left ventricular assist devices (VADs or LVADs) as a long-term solution for advanced heart failure instead of a full heart transplant. As more patients choose heart-assist devices instead of surgery, manufacturers are working to identify new options that serve both short-term and long-term purposes.

Those who use the device in the short term ("bridge-to-transplant") use it as an interim solution to support their failing heart while waiting for a heart transplant. In those cases, the device may be used for weeks, months and even years until an organ match is found. Those who use the device long term ("destination therapy") use it indefinitely to supplement pumping functions in the heart.

Heart failure affects more than 5 million Americans and is diagnosed in 800,000 new patients per year.

The Momentum III U.S. IDE clinical trial is the first to study both short- and long-term implications of the device.

"In previous VAD trials, the device was initially evaluated as a bridge-to-transplant. And then another trial had to be conducted for destination therapy," Dr. Hall said. "If the results of this trial are positive, it will speed up the process of approval by literally years, making this LVAD available to patients that much sooner."

Baylor is one of 60 centers participating in the large-scale research that includes a national participant pool of 1,000 patients.

About BRI
Established in 1984 in Dallas, Texas, Baylor Research Institute (BRI) promotes and supports research to bring innovative treatments from the laboratory workbench to the patient bedside. To achieve this bench-to-bedside concept, BRI focuses on basic science, clinical trials, health care effectiveness and quality-of-care research. Today, BRI is conducting more than 1,000 active research protocols with 335 research investigators, spanning more than 43 medical specialties. BRI has research and development projects in areas ranging from human immunology and orphan metabolic diseases to diabetes, cardiovascular disease and many other unmet medical needs. Its Personalized Medicine arm offers a unique platform for identifying microarray-based fingerprint signatures. Baylor Scott &White Health offers its research affiliates unique access to one of the largest patient bases available for research in the US within a single institution. BRI has received full accreditation from AAHRPP.

www.baylorhealth.edu/research

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